an open-source thought experiment in psychedelic law and policy

"Currently accepted medical use in treatment," A/K/A the end game

That which stands between the current human condition and an alternative mode of existence is 21 U.S.C. Section 812(b)(1)(B).

That statutory citation, in plain English, is the “medical use” prong of Schedule I of the Controlled Substances Act, the knot at the heart of drug prohibition.

Section 812 of the CSA states the elements of the Schedules into which first the Congress in 1970 placed and in which the DEA continues to maintain (some) psychoactive substances.

The criteria for classification in Schedule I are as follow:

(A) The drug or other substance has a high potential for abuse.

(B) The drug or other substance has no currently accepted medical use in treatment in the United States.

(C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.

That is the legal home, or should I say the “House of Detention” (to quote The Doors, “When the Music’s Over”) in which reside cannabis, LSD, MDMA, psilocybin, ibogaine, ayahuasca and mescaline, among other psychedelics.

Psychoactive substances can pass legally in interstate commerce only in accordance with the CSA. The CSA provides no mechanism by which Schedule I substances can move in interstate commerce, i.e. at all. The CSA prohibits the cultivation, manufacture, sale and purchase of Schedule I psychedelics except as the statute permits. Take a look at Section 829 of the CSA, the section governing prescriptions for controlled substances. This section is the statutory basis for physicians to prescribe drugs such as opiates and amphetamines. What does not appear at Section 829? Schedule I substances. Since the federal government does not recognize any medical use of Schedule I substances, no physician may prescribe them. Not even a physician may prescribe them…so surely none of the rest of us may self-administer, administer to others, or participate in facilitating administration.

There you have it. That is how psychedelic prohibition works.

It is the medical use prong that sets Schedule I apart from all the other schedules. Each of the schedules looks to the same criteria: abuse potential, medical use, and safety. In each of the four lower schedules – each of which corresponds to a progressively less-restrictive distribution scheme – at item (B) the statute states that there is a currently accepted medical use in treatment. Again, the distinguishing characteristic of Schedule I is NO medical use. I have said before that the essence of “drug prohibition” (a highly non-technical term which I dislike but I will use for the sake of convenience) is the criminal prohibition of all use of psychoactive substances except for medical use – construed as narrowly as possible. Under this analysis, in the case of Schedule I there is no medical exception, as a matter of law.

When DEA representatives and publications say that marijuana is not a medicine, they are referencing the “currently accepted medicine use in treatment” scheduling criterion.

So what does it mean?

Buford Terrell, a retired law professor in Houston, and one of my regular correspondents, has offered an an analysis of the phrase which I find totally totally totally fascinating. To my eye it is THE essence – the “missing link” – of the debate over drug control and, frankly, I consider insufficient any argument that does not address the issues he discusses. I am not aware of any analysis that addresses these issues and I believe that the arguments about federal control are insufficient without this argument.

I am very pleased that he has posted an analysis of two possible constructions of that phrase, the one which he says the DEA favors, one that imprisons humanity in its current condition, i.e. an existence in which psychedelics are not integrated into society as legitimate tools of therapy and personal growth, and the one that opens the door to an alternative existence.

I have said in the past in other places that there is an obvious problem with the phrase “currently accepted medical use in treatment.” Aside from the questions what does “medical use” mean, what does “in treatment” mean and what does “medical use in treatment” mean, I want to know who does the “accepting”? (We could also ask what does “currently” mean in this context.) This element is phrased in the passive voice. Accepted by …. a doctor? a patient? the American Medical Association? the World Health Organization? Medicaid? the DEA Administrator? It’s the zillion dollar question (or perhaps I should say, the question should be valued at the cost over the last forty years of prohibiting any use of cannabis).

Buford addresses this topic head on. He posits that there are two ways of construing phrase: (a) the DEA checks to see whether the FDA has approved the substance or (b) the DEA checks to see how doctors as a matter of fact treat the substance. (I paraphrase.) He argues for the second, addressing the crucial question of whether the US Constitution permits the federal government to regulate the practice of medicine. He says no. If he’s right, then the game is over. If the DEA may only ascertain whether doctors … and we may also argue for patients, their families/caregivers, nurses and other allied health professionals, hospital administrators, public health officials…ACTUALLY consider the substance to be useful “medically” (we can revisit what THAT means), then the DEA must reschedule the substance.

Here is a (large) excerpt from his post:

The second possible meaning is that the issue is strictly one of demographics. Under this theory, the DEA has no competency to examine the scientific and medical questions, but must limit itself to determining what, in fact, doctors do in the course of treating patients. In other words, the question becomes one of whether a substantial number of doctors treat marijuana or MDMA is a therapeutic agent when dealing with their patients and whether other doctors approve or disapprove of that use.

An examination of the development of the regulation of both legal and illegal drugs indicates that the second reading, limiting the DEA to the question of what doctors do in practice, is more consistent with current constitutional law. That story began soon after the enactment of the Harrison Narcotic Tax Act in 1914.

That act criminalized a doctor’s dispensing or prescribing an opiate to a patient outside of the normal course of medical practice. The government began prosecuting doctors who furnished morphine or heroin for the purpose of maintaining their habits (much like methadone is used today), claiming that maintaining addicts in a stable, functioning life was not part of the normal practice of medicine.

The Supreme Court considered that question three times before deciding that Congress had no constitutional authority to say what was “the practice of medicine”. In Linder (1925) the Court held that medical practice was not part of interstate commerce and, consequentially, the power to regulate medicine, including determination of what is or is not medicine, is reserved solely to the states.

While the Supreme Court has discussed medical marijuana in over twenty opinions, it has not directly dealt with this problem of interpretation of the CSA. However, in Conant v. Walters (2002), the Ninth Circuit applied this reasoning in holding that the federal government, acting under the CSA, could not prevent a state-licensed doctor from recommending the use of marijuana to a patient. So far the DEA has not presented the issue to another circuit.

Congress was faced with this exclusion of the federal government from the regulation of medicine when it created the Food and Drug Administration through the Food, Drug, and Cosmetics Act in the 1930s. The purpose of the act was to insure food and drug safety, but since Congress could not regulate drugs directly, indirect action was called for.

Consequently, the FDA was not given power to approve drugs, but instead, it was empowered to prevent drugs from being sold in a deceptive or misleading manner. A drug sale would be misleading and deceptive unless that drug bore a label approved by the FDA. That label would be approved only if it were substantiated by valid scientific tests that the drug was safe for the intended use.

That method of regulating drugs by controlling their marketing was continued as the FDCA was amended, first in the1950s to separate prescription and over-the-counter drugs and then in the 1960s to require scientific proof of efficacy for at least one medical use before a label could be approved. The Supreme Court has approved this distinction in cases involving the rights of doctors to prescribe drugs for “off label” uses, treatment of conditions not included on the label, although manufacturers have been punished for publicizing or advertising those uses. Doctors distributing drugs which they themselves had produced and furnished to their own patients as part of a broader therapy and not using the instrumentalities of interstate commerce have also been held to be outside the jurisdiction of the FDA. The most recent case, Gonzales v. Oregon (2006), prevented the DEA from taking action against doctors acting under Oregon’s assisted suicide law.

…

This constitutional derivation strongly favors the interpretation that the DEA is limited to asking only what doctors are, in fact, doing and is barred from inquiring into the medical or scientific value of the drug. The statutory language itself reinforces this interpretation. The statute specifies “currently accepted medical use”; Congress could have easily used “medically effective” or “substantial medical value” if the intent had been to empower the DEA to conduct independent scientific investigations. Congress did, in fact, empower the FAA, FCC, and NTSB with those kinds of direct powers in regulating airplanes, broadcast stations, and trucks and buses: all direct instrumentalities of interstate commerce.

The DEA’s own Administrative Law Judge applied a “medical use” standard in the first two contested scheduling proceedings under the CSA: the first marijuana petition and the proceeding for the emergency scheduling of MDMA. The politically appointed Administrator reversed his recommendations in both cases. In the MDMA proceeding, the Administrator rejected the ALJ’s findings, equating “medical use” with “approved by the FDA”. The Court of Appeals (Grinspoon, First Circuit, 1987) rejected this interpretation and remanded the case for further consideration.

If the courts were to require the DEA to use a medical use standard instead of a medical value standard, rescheduling of marijuana and MDMA would necessarily follow, allowing them to be sold through normal medical channels; and the rescheduling of psilocybin, LSD, mescaline, and possibly heroin and ibogaine would be likely. These drugs, while having no, or little, current medical use, could be covered by a “but for…” argument. Each of them had thriving medical use and widespread favorable medical reporting before they were classified as Schedule I drugs. But for that classification, their medical use would probably be common today. Heroin, for instance, is routinely used in many countries with developed, sophisticated medical systems. This information would be probative in a rescheduling action. If coupled with expert opinions about the scope of its use by American physicians and pharmacologists, it should be persuasive.

Translation: the DEA says that the law says that there is no medical use of cannabis (or MDMA or LSD or ibogaine) because the FDA has not said that there is a medical use and therefore there is no medical use. However, the FDA does not say that whether or not there is a medical use of a substance. It permits marketing and distribution of a drug if it passes the FDA’s tests for efficacy.

2 thoughts on “"Currently accepted medical use in treatment," A/K/A the end game”

yes, this is essentially my understanding. I should add that another criterion that sets apart Schedule I from II is the “no accepted level of safety for use under medical supervision” — this too is moreso dependent to day-to-day medical practice and consensus rather than some Orwellian drug regulatory scheme